MAUDE Adverse Event Report: CORCYM S.R.L. MEMO 4D ANNULOPLASTY RING; MITRAL ANNULOPLASTY RING

Model Number	4DM-26
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the memo 4d annuloplasty ring 4dm-26 was used for a mitral valve repair.After stitching the ring, the transparent holder was removed by cutting the blue thread at two points.To detach the blue holder from the ring, the white thread was cut at one point; however it was reportedly difficult to detach the blue holder from the ring.The surgeon had no choice but to cut the u-shaped thread one by one, and was able to detached the blue holder with an effort.However, the threads remained on the ring side, and it was very hard to remove them one by one.
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Given that the memo 4d ring was ultimately implanted, no device investigation is possible at this time.Further investigation is ongoing.Device remains implanted.

• Brand Name: MEMO 4D ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 14380423
• Report Number: 3005687633-2022-00124
• Device Sequence Number: 17828273
• Product Code: KRH
• UDI-Device Identifier: 08022057015419
• UDI-Public: (01)08022057015419(240)4DM-26(17)260606
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2026
• Device Model Number: 4DM-26
• Device Catalogue Number: 4DM-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown